Expandable fixation elements for subcutaneous electrodes

ABSTRACT

Subcutaneous systems and leads may be fixed in tissue after placement by use of one or more expanding fixation elements. An expanding fixation element is provided on an implantable lead and configured to secure one or both of a subcutaneous electrode and the lead body within subcutaneous non-intrathoracic tissue. A delivery apparatus comprising a sheath may be included that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location within the patient. A method of lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead comprising a lead body and an electrode, and advancing the lead through the sheath and to the subcutaneous non-intrathoracic body location. The method further involves fixing the lead to subcutaneous non-intrathoracic tissue using an expanding fixation element and thereafter removing the sheath from the patient.

RELATED APPLICATIONS

[0001] This application claims the benefit of Provisional PatentApplication Serial No. 60/462,272, filed on Apr. 11, 2003, to whichpriority is claimed pursuant to 35 U.S.C. §119(e) and which is herebyincorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to leads forsubcutaneously implantable cardiac monitoring and/or stimulationdevices, and, more particularly, to expandable fixation elements forsubcutaneous electrodes.

BACKGROUND OF THE INVENTION

[0003] Implantable cardiac rhythm management systems have been used asan effective treatment for patients with serious arrhythmias. Thesesystems typically include one or more leads and circuitry to sensesignals from one or more interior and/or exterior surfaces of the heart.Such systems also include circuitry for generating electrical pulsesthat are applied to cardiac tissue at one or more interior and/orexterior surfaces of the heart. For example, leads extending into thepatient's heart are connected to electrodes that contact the myocardiumfor monitoring the heart's electrical signals and for delivering pulsesto the heart in accordance with various therapies for treatingarrhythmias.

[0004] Typical implantable cardioverter/defibrillators (ICDs) includeone or more endocardial leads to which at least one defibrillationelectrode is connected. Such ICDs are capable of delivering high-energyshocks to the heart, interrupting the ventricular tachyarrythmia orventricular fibrillation, and allowing the heart to resume normal sinusrhythm. ICDs may also include pacing functionality.

[0005] Although ICDs are very effective at preventing Sudden CardiacDeath (SCD), most people at risk of SCD are not provided withimplantable defibrillators. Primary reasons for this unfortunate realityinclude the limited number of physicians qualified to performtransvenous lead/electrode implantation, a limited number of surgicalfacilities adequately equipped to accommodate such cardiac procedures,and a limited number of the at-risk patient population that may safelyundergo the required endocardial or epicardial lead/electrode implantprocedure. For these reasons, subcutaneous ICDs are being developed.

[0006] Current ICDs utilize subcutaneous electrodes that may be prone tomigrate in the subcutaneous tissue layer due to, for example, gravity,patient mobility, or patient interaction (e.g., twiddler's syndrome).Such migration may be detrimental to the performance of a subcutaneouselectrode system because monitoring, detection, and defibrillationefficacy is typically very sensitive to electrode position/orientation.

[0007] Existing subcutaneous leads have typically relied on redundancyto address the problem of subcutaneous electrode migration. For example,a subcutaneous array may include three long coil electrodes, even thoughall three coils are not necessary when properly placed. Becausemigration may occur, the three long fingers provide adequate coverage tomaintain defibrillation efficacy.

[0008] There is a need for more precise electrode placement that solvesthe problem of subcutaneous electrode migration. There is a further needfor a fixation approach for subcutaneous leads that provides forimproved subcutaneous system performance, such as by providing moreconsistent defibrillation and/or pacing thresholds and potentiallylowering such thresholds. The present invention fulfills these and otherneeds, and addresses deficiencies in known systems and techniques.

SUMMARY OF THE INVENTION

[0009] The present invention is directed to subcutaneous systems andleads that, in general, can be fixed in tissue after placement.Embodiments of the present invention are directed to subcutaneous leadsthat incorporate one or more expanding fixation elements. Furtherembodiments of the present invention are directed to methods ofplacement and methods of fixation of subcutaneously implantable leads.

[0010] An implantable lead in accordance with an embodiment of thepresent invention is directed to a lead body with a supported electrode.The electrode is configured for subcutaneous non-intrathoracic placementwithin a patient. An expanding fixation element is provided on theimplantable lead and configured to secure one or both of thesubcutaneous electrode and the lead body in subcutaneousnon-intrathoracic tissue. A delivery apparatus comprising a sheath maybe included that is configured to introduce the lead to a desiredsubcutaneous non-intrathoracic location within the patient.

[0011] Another embodiment of the present invention is directed to amethod of lead delivery involving introducing a sheath into asubcutaneous non-intrathoracic body location of a patient, providing alead comprising a lead body and an electrode, and advancing the leadthrough the sheath and to the subcutaneous non-intrathoracic bodylocation. The method further involves fixing the lead to subcutaneousnon-intrathoracic tissue using an expanding fixation element andthereafter removing the sheath from the patient. The method may alsoinvolve longitudinally splitting the sheath when retracting the sheathfrom the patient and enabling an expandable fixation element forengagement with subcutaneous non-intrathoracic tissue.

[0012] The above summary of the present invention is not intended todescribe each embodiment or every implementation of the presentinvention. Advantages and attainments, together with a more completeunderstanding of the invention, will become apparent and appreciated byreferring to the following detailed description and claims taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013]FIGS. 1A and 1B are views of a transthoracic cardiac monitoringand/or stimulation device as implanted in a patient;

[0014]FIG. 2 illustrates a lead in accordance with the presentinvention, inserted in a dissected subcutaneous path leading from thecan;

[0015]FIG. 3A is a plan view of a lead enclosed within a sheath prior todeployment of fixation elements in accordance with the presentinvention;

[0016]FIGS. 3B and 3C are plan views of a lead having an expandingregion before (FIG. 3B) and after (FIG. 3C) expansion in accordance withthe present invention;

[0017]FIG. 4 is a magnified view of one embodiment of a lead having anelectrode, the lead implemented to include fixation arrangements inaccordance with the present invention;

[0018]FIG. 5 is a magnified view of another embodiment of a lead havingan electrode, the lead implemented to include fixation arrangements inaccordance with the present invention;

[0019]FIG. 6 is a magnified view of a further embodiment of a leadhaving an electrode, the lead implemented to include fixationarrangements in accordance with the present invention;

[0020]FIG. 7 is a magnified view of yet another embodiment of a leadhaving an electrode, the lead implemented to include fixationarrangements in accordance with the present invention;

[0021]FIG. 8A is a magnified view of a further embodiment of a leadhaving an electrode, the lead implemented to include fixationarrangements in accordance with the present invention;

[0022]FIG. 8B is an end view of the embodiment illustrated in FIG. 8A;

[0023]FIG. 9A is a magnified view of another embodiment of a lead havingan electrode, the lead implemented to include a fixation arrangement inaccordance with the present invention;

[0024]FIG. 9B is an end view of the embodiment illustrated in FIG. 9A;

[0025]FIG. 9C is a magnified view of another embodiment of a lead havingan electrode, the lead implemented to include a fixation arrangement inaccordance with the present invention;

[0026]FIG. 9D is an end view of the embodiment illustrated in FIG. 9C;

[0027]FIG. 9E is a magnified view of another embodiment of a lead havingan electrode, the lead implemented to include a fixation arrangement inaccordance with the present invention;

[0028]FIG. 9F is an end view of the embodiment illustrated in FIG. 9E;

[0029]FIG. 9G is a magnified sectional view of another embodiment of alead implemented to include a fixation arrangement in accordance withthe present invention;

[0030]FIGS. 10A, 10B, 10C and. 10D are sectional views of various timesin accordance with the present invention;

[0031]FIG. 11 illustrates a lead in accordance with the presentinvention, inserted in a dissected subcutaneous path leading from thecan, where an offset helical electrode/fixation element is illustratedfixed to the tissue;

[0032]FIG. 12 is a plan view of a lead enclosed within a sheath prior todeployment of a fixation element in accordance with the presentinvention;

[0033]FIG. 13 is a magnified view of one embodiment of a lead having anelectrode, the lead implemented to include a fixation arrangement inaccordance with the present invention;

[0034]FIG. 14 is a magnified end view of the embodiment of FIG. 13;

[0035]FIG. 15 is a magnified view of a further embodiment of a leadhaving an electrode, the lead implemented to include a fixationarrangement in accordance with the present invention; and

[0036]FIG. 16 is a magnified end view of the embodiment of FIG. 15.

[0037] While the invention is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail below. It is to beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the invention isintended to cover all modifications, equivalents, and alternativesfalling within the scope of the invention as defined by the appendedclaims.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

[0038] In the following description of the illustrated embodiments,references are made to the accompanying drawings, which form a parthereof, and in which is shown by way of illustration various embodimentsin which the invention may be practiced. It is to be understood thatother embodiments may be utilized, and structural and functional changesmay be made without departing from the scope of the present invention.

[0039] A device employing an implantable lead implemented in accordancewith the present invention may incorporate one or more of the features,structures, methods, or combinations thereof described herein below. Forexample, a subcutaneous cardiac monitor or stimulator may be implementedto include one or more of the features and/or processes described below.It is intended that such a device or method need not include all of thefeatures and functions described herein, but may be implemented toinclude selected features and functions that, in combination, providefor unique structures and/or functionality.

[0040] In general terms, an implantable lead implemented in accordancewith the present invention may be used with a subcutaneous cardiacmonitoring and/or stimulation device. One such device is an implantabletransthoracic cardiac monitoring and/or stimulation (ITCS) device thatmay be implanted under the skin in the chest region of a patient. TheITCS device may, for example, be implanted subcutaneously such that allor selected elements of the device are positioned on the patient'sfront, back, side, or other body locations suitable for monitoringcardiac activity and delivering cardiac stimulation therapy. It isunderstood that elements of the ITCS device may be located at severaldifferent body locations, such as in the chest, abdominal, or subclavianregion with electrode elements respectively positioned at differentregions near, around, in, or on the heart.

[0041] The primary housing (e.g., the active or non-active can) of theITCS device, for example, may be configured for positioning outside ofthe rib cage at an intercostal or subcostal location, within theabdomen, or in the upper chest region (e.g., subclavian location, suchas above the third rib). In one implementation, one or more electrodesmay be located on the primary housing and/or at other locations about,but not in direct contact with the heart, great vessel or coronaryvasculature.

[0042] In another implementation, one or more leads incorporatingelectrodes may be located in direct contact with the heart, great vesselor coronary vasculature, such as via one or more leads implanted by useof conventional transvenous delivery approaches. In anotherimplementation, for example, one or more subcutaneous electrodesubsystems or electrode arrays may be used to sense cardiac activity anddeliver cardiac stimulation energy in an ITCS device configurationemploying an active can or a configuration employing a non-active can.Electrodes may be situated at anterior and/or posterior locationsrelative to the heart.

[0043] Referring now to FIGS. 1A and 1B of the drawings, there is showna configuration of an ITCS device implanted in the chest region of apatient at different locations by use of a dissection tool. In theparticular configuration shown in FIGS. 1A and 1B, the ITCS deviceincludes a housing 102 within which various cardiac monitoring,detection, processing, and energy delivery circuitry may be housed. Thehousing 102 is typically configured to include one or more electrodes(e.g., can electrode and/or indifferent electrode). Although the housing102 is typically configured as an active can, it is appreciated that anon-active can configuration may be implemented, in which case at leasttwo electrodes spaced apart from the housing 102 are employed. An ITCSsystem according to this approach is distinct from conventionalapproaches in that it is preferably configured to include a combinationof two or more electrode subsystems that are implanted subcutaneously.

[0044] In the configuration shown in FIGS. 1A and 1B, a subcutaneouselectrode 104 may be positioned under the skin in the chest region andsituated distal from the housing 102. The subcutaneous and, ifapplicable, housing electrode(s) may be positioned about the heart atvarious locations and orientations, such as at various anterior and/orposterior locations relative to the heart. The subcutaneous electrode104 is electrically coupled to circuitry within the housing 102 via alead assembly 106. One or more conductors (e.g., coils or cables) areprovided within the lead assembly 106 and electrically couple thesubcutaneous electrode 104 with circuitry in the housing 102. One ormore sense, sense/pace or defibrillation electrodes may be situated onthe elongated structure of the electrode support, the housing 102,and/or the distal electrode assembly (shown as subcutaneous electrode104 in the configuration shown in FIGS. 1A and 1B).

[0045] In one configuration, the lead assembly 106 is generallyflexible. In another configuration, the lead assembly 106 is constructedto be somewhat flexible, yet has an elastic, spring, or mechanicalmemory that retains a desired configuration after being shaped ormanipulated by a clinician. For example, the lead assembly 106 mayincorporate a gooseneck or braid system that may be distorted undermanual force to take on a desired shape. In this manner, the leadassembly 106 may be shape-fit to accommodate the unique anatomicalconfiguration of a given patient, and generally retains a customizedshape after implantation. Shaping of the lead assembly 106 according tothis configuration may occur prior to, and during, ITCS deviceimplantation.

[0046] In accordance with a further configuration, the lead assembly 106includes a rigid electrode support assembly, such as a rigid elongatedstructure that positionally stabilizes the subcutaneous electrode 104with respect to the housing 102. In this configuration, the rigidity ofthe elongated structure maintains a desired spacing between thesubcutaneous electrode 104 and the housing 102, and a desiredorientation of the subcutaneous electrode 104/housing 102 relative tothe patient's heart. The elongated structure may be formed from astructural plastic, composite or metallic material, and includes, or iscovered by, a biocompatible material. Appropriate electrical isolationbetween the housing 102 and the subcutaneous electrode 104 is providedin cases where the elongated structure is formed from an electricallyconductive material, such as metal.

[0047] In one configuration, the rigid electrode support assembly andthe housing 102 define a unitary structure (i.e., a singlehousing/unit). The electronic components and electrodeconductors/connectors are disposed within or on the unitary ITCS devicehousing/electrode support assembly. At least two electrodes aresupported on the unitary structure near opposing ends of thehousing/electrode support assembly. The unitary structure may have, forexample, an arcuate or angled shape.

[0048] According to another configuration, the rigid electrode supportassembly defines a physically separable unit relative to the housing102. The rigid electrode support assembly includes mechanical andelectrical couplings that facilitate mating engagement withcorresponding mechanical and electrical couplings of the housing 102.For example, a header block arrangement may be configured to includeboth electrical and mechanical couplings that provide for mechanical andelectrical connections between the rigid electrode support assembly andhousing 102. The header block arrangement may be provided on the housing102 or the rigid electrode support assembly or both. Alternatively, amechanical/electrical coupler may be used to establish mechanical andelectrical connections between the rigid electrode support assembly andthe housing 102. In such a configuration, a variety of differentelectrode support assemblies of varying shapes, sizes, and electrodeconfigurations may be made available for physically and electricallyconnecting to a standard ITCS device.

[0049] It is noted that the electrodes and the lead assembly 106 may beconfigured to assume a variety of shapes. For example, the lead assembly106 may have a wedge, chevron, flattened oval, or a ribbon shape, andthe subcutaneous electrode 104 may include a number of spacedelectrodes, such as an array or band of electrodes. Moreover, two ormore subcutaneous electrodes 104 may be mounted to multiple electrodesupport assemblies 106 to achieve a desired spaced relationship amongstthe subcutaneous electrodes 104. Accordingly, subcutaneous leads of thepresent invention may be shaped appropriately for specific electrodes orfamilies of electrodes and electrode support assemblies.

[0050] The ITCS device may be used within the structure of an advancedpatient management (APM) system. Advanced patient management systems mayallow physicians to remotely and automatically monitor cardiac andrespiratory functions, as well as other patient conditions. In oneexample, implantable cardiac rhythm management systems, such as cardiacpacemakers, defibrillators, and resynchronization devices, may beequipped with various telecommunications and information technologiesthat enable real-time data collection, diagnosis, and treatment of thepatient. Various embodiments described herein may be used in connectionwith advanced patient management. Methods, structures, and/or techniquesdescribed herein, which may be adapted to provide for remotepatient/device monitoring, diagnosis, therapy, or other APM relatedmethodologies, can incorporate features of one or more of the followingreferences: U.S. Pat. Nos. 6,221,011; 6,270,457; 6,277,072; 6,280,380;6,312,378; 6,336,903; 6,358,203; 6,368,284; 6,398,728; and 6,440,066,which are hereby incorporated herein by reference.

[0051] Referring now to FIG. 2, an ITCS system 200 is illustrated whichincludes a can 250 with a lead 241 inserted into a subcutaneousdissection path 220. The lead 241 includes an electrode 230 and a leadbody 240. The electrode 230 is here illustrated at the distal end of thelead body 240. The subcutaneous dissection path 220 lies withinsubcutaneous tissue of a patient as illustrated in FIGS. 1A and 1B. Thelead 241 may be inserted into the subcutaneous dissection path 220 byitself, or may also be inserted with use of a sheath 320 as illustratedin FIG. 3A.

[0052] In FIG. 3A, a proximal end of the lead body 240 extends from thesheath 320, with the electrode 230 enclosed within the lumen of thesheath 320. The electrode 230 is illustrated that includes fixationelements 232 and 234 respectively provided at distal and proximal endsof the electrode 230. It should be understood that any number of suchfixation elements may be employed to fix the electrode 230 withinsubcutaneous tissue.

[0053] The fixation elements 232 and 234 may include, for example, anexpandable fixation mechanism, such as a spongy material that ispreferably, but not necessarily, compressed within the lumen of thesheath 320 during delivery. According to one delivery approach, the lead241 may be inserted into the dissection path, such as dissection path220 shown in FIG. 2, while inside the sheath 320. After positioning thesheath 320 at the desired location within subcutaneous tissue, thesheath 320 may be retracted or otherwise separated from the lead 241.Retracting the sheath 320 from the electrode 230 and the lead body 240permits the fixation elements 232 and 234 to expand and affix theelectrode 230 within the subcutaneous tissue.

[0054] A suitable material for constructing the fixation elements 232and 234 is scleral sponge. However, the fixation elements 232 and 234may be constructed from any implantable material capable of expansion.Expansion of the fixation elements 232 and 234 may occur due to theirrelease from the sheath 320, from uptake of body fluid, from an injectedmaterial, or other means of expansion. For example, a fluid may beinjected into an expandable balloon fixation element with a one-wayvalve or stopper.

[0055] Other embodiments of expanding fixation elements are illustratedin FIGS. 3B and 3C. In FIG. 3B, an expanding collar 330 and an expandinglead portion 340 are illustrated in their respective pre-expansionconfigurations. The expanding collar 330 and lead portion 340 may, forexample, be components made of a mixture of a biocompatible polymer anda water-soluble additive. By way of illustration, silicone rubber and awater-soluble additive such as glycerol represent one combination ofmaterials useful for producing the expanding collar 330 and theexpanding lead portion 340.

[0056] For example, the expanding collar 330 and/or lead portion 340 mayinclude more than one additive and/or concentrations of one or moreadditives. At a first additive concentration, by way of illustration,the expanding collar 330 and/or lead portion 340 may expand for acutefixation, and remain expanded for continued chronic fixation. At asecond additive concentration, by way of further illustration, theexpanding collar 330 and/or lead portion 340 may expand for acutefixation, and the additive may then subsequently dissolve to providepores that promote chronic tissue ingrowth. Similarly, a first additivemay provide expansion and a second additive may provide porosity afterthe second additive is dissolved.

[0057] The expanded tip or collar 330 may itself provide a press-fit inthe surrounding subcutaneous tissue, ensuring fixation, or may alsoprovide porosity for promoting tissue ingrowth. By using othercompositions, the additive(s) within the material may create pocketsthat combine within the component sufficiently to create pores thatcommunicate with the component surface, which promotes tissue ingrowth.An example of additives that require a containment matrix or scaffoldingfor support include, but are not limited to, water soluble materialssuch as glycerol, mannitol, sodium chloride, and potassium chloride, aswell as water soluble pharmaceutical agents such as, for example,dexamethasone sodium phosphate.

[0058] In another example involving use of expanding materialcompositions, an expanding polymer may be used alone or in combinationwith non-expanding polymers or other expanding materials. For example, ahydrogel may be used as an expanding polymeric additive to anon-expanding silicone, or in combination with an expanding materialsuch as glycerol as is described above. A non-exhaustive, non limitinglist of hydrogels useful in accordance with the present inventionincludes methyl methacrylate, poly(2-hydroxyethel methacrylate) gel,methacrylic acid, and other polyacid gels and methacrylate hydrogels.

[0059] Provision of an expanding polymer within or on an implantablelead body or lead component may provide for one or more of acuteexpanding fixation only, acute and chronic expanding fixation, and acuteexpanding fixation with dissolution of a non-polymeric additive forpromoting tissue ingrowth and subsequent chronic fixation. Anon-exhaustive non-limiting listing of expandable polymers useful inaccordance with the present invention includes: vinylpyrrolidone,silicone rubber, polyurethane, polyacrylamide, and polyvinylpyrrolidone.

[0060] Polymeric expansion can be achieved in at least three ways. Byway of a first example, a polymer may absorb environmental water in oneof two fashions. Polymers that expand according to the first fashion arecompounded with one or more of the additives listed above. The isolatedadditive inclusions will dissolve as water penetrates the polymer. Sincethe concentration of water in the isolated additive inclusion site wouldbe less than that of the outer environment, water would naturallycontinue to enter the inclusion site, thereby bringing about expansion.This process would terminate once the growing internal “bubble” ofadditive solution encountered sufficient internal polymeric forces. Inthe event that the strength of the polymer was insufficient to generatethose counteracting forces, the bubble would continue to grow until thebubble burst and the additive solution was released to the environment.This process would take place with any of the polymers listed.

[0061] Polymers that expand according to the second fashion absorbenvironmental water, and are usually provided initially in a dry state.Water or fluid absorption causes the polymeric component to expand. Thisis one mechanism for the hydrogel polymers list above. In the case ofosmotic swelling utilizing an expanding polymer the absorbed watersupplied by the body's aqueous environment penetrates the polymer toprovide component expansion. The subsequent reaction forces generatedwithin the material eventually balance the osmotic forces so thatdestructive expansion does not occur.

[0062] A second way expansion can be achieved uses a polymer that isexposed to changes in environmental pH. This is the case for some of thehydrogel formulations listed above. For example, a polymer such as thepoly(2-hydroxyethel methacrylate) gel described above exhibitspolymorphism of the polymer chain structure as pH changes. In a firststate, the polymer may have a first structure that undergoes a changewhen it is immersed into the body's aqueous environment. Theenvironmental pH will cause the polymer to change to a second structure,and bring about an expansion of the material. Further, the pH-sensitivepolymers may also experience still further expansion when formulatedwith one or more additives listed above.

[0063] A third way expansion can be achieved uses a polymer that isexposed to an environment containing mobile substances, other thanwater, that would leave that environment to enter or partition into thepolymer. A well-known example of this type of expansion is the uptake oflipid-like substances from the blood by early silicone rubberformulations such as materials used to manufacture early artificialheart valve poppets. Over time, after implantation, these siliconerubber poppets “soaked up” enough lipid-like substances to change theshape of the poppet and, in some cases, cause undesired valve failure.Modern formulations of silicone rubber are now available that do notexhibit this lipid-uptake behavior. However, the early formulations ofsilicone rubber may be beneficial for applications such as in thepresent invention. The absorption of lipid-like substances into apolymer, such as early formulation silicone, would bring about desiredexpansion to achieve fixation. Further, this expansion would be basedupon a polymeric formulation, and not need the inclusion of additives toprovide fixation.

[0064] In general, expandable polymer materials change shape in responseto changes in their environment. Expanding polymers may be used bythemselves, solely providing expansion, or may be used in combinationwith non-polymeric additives and/or other non-expanding polymers.

[0065]FIG. 3C illustrates an expanded collar 350 and an expanded leadportion 360. After implantation, collar 330 and lead portion 340 (shownin FIG. 3B) expand, and transform into expanded collar 350 and expandedlead portion 360. The expanded collar 350 and portion 360 may beemployed in combination and/or by themselves, to fix the lead 241 intotissue.

[0066] Turning now to FIG. 4, there is illustrated an embodiment of thelead 241 that includes an electrode 230 provided with another fixationarrangement. The lead 241 is shown to include the electrode 230 nowhaving tines 410, 420, 430, 440, 450, and 460 projecting outwardly fromthe body of the electrode 230/lead body 240. Also illustrated are anumber of diagonal grooves 470, 471, 472, 473, and 474.

[0067] The tines 410-460 are shown biased away from the lead body 240by, for example, manufacturing the times 410-460 using a mechanicallyelastic material having spring-like qualities such as, for example,metal or plastic. The tines 410-460 may be angled away and proximallyoriented, as illustrated in FIG. 4, to allow the lead 241 to be easilyinserted into the dissection path in a distal direction, but resistbeing pulled out in a proximal direction. The tines 410-460 provide forboth acute and chronic fixation of the lead 241 into subcutaneoustissue.

[0068] After placement and acute fixation of the lead 241 withinsubcutaneous tissue, the grooves 470-474 provide regions for promotingtissue ingrowth, which chronically fixes the lead 241 within thesubcutaneous tissue. The grooves 470-474 are denoted by a series ofparallel lines oriented diagonally relative to a longitudinal axis ofthe lead body 240. It is contemplated that any number of grooves may beimplemented at any angle or at varying angles. For example, acrosshatched pattern of grooves 510, as is illustrated in FIG. 5, may beincorporated to promote tissue ingrowth after placement of the lead 241within subcutaneous tissue. The grooves 470-474 may be of any suitablesize, shape, depth or spacing.

[0069] As illustrated in FIG. 6, one or more ridges 610 may be used incombination with, or in lieu of, grooves for chronic tissue purchase.The ridges 610 may be configured to provide for chronic fixation of thelead body 240 resulting from tissue ingrowth. Both grooves 510 (FIG. 5)and ridges 610 may also provide a degree of acute fixation, depending onthe size of the grooves 510 or ridges 610. Acutely, the grooves 510 orridges 610 would provide an initial purchase with the tissue. As timeprogresses, the initial immature encapsulation will constrict, resultingin a more firm purchase on the lead 241. As is further illustrated inFIG. 6, a plurality of tines 620, 630, 640, 650, 660, and 670 may beused in combination with other fixation techniques for purposes ofacutely fixing the lead body 240 and/or a lead electrode, as describedearlier. Features such as the plurality of tines 620, 630, 640, 650,660, and 670 may be located on the lead body 240 and/or the electrode230. The tines 620-670 and/or the ridges 610 and/or grooves may be usedin various combinations along with other acute fixation techniques knownin the art, such as, for example, a suture attachment point (not shown)on the lead 241.

[0070] Referring now to FIG. 7, another fixation arrangement inaccordance with the present invention is illustrated. According to thisembodiment, the fixation arrangement includes one or more texturedsurfaces or regions 710 on the lead body 240 and/or an electrode 230 ofthe lead 241. The textured surface(s) 710 may be employed as a solechronic fixation method or in combination with other chronic fixationarrangements, such as a set of grooves 720 as is depicted in FIG. 7.

[0071] The textured surface 710 promotes tissue ingrowth to provide forchronic fixation of the lead body 240 into subcutaneous tissue. Thetextured surface 710 may be, for example, a porous region of the leadbody 240, a coating having surface irregularities, dimples molded intothe lead body 240 and/or a lead electrode 230, surface treatments frommanufacturing processes such as sanding or scratching, or other suitabletexturing.

[0072] Generally at least one acute fixation mechanism is employed incombination with chronic fixation mechanism, to allow sufficient timefor the fixing of the chronic fixation mechanism into the subcutaneoustissue. An appropriate acute fixation mechanism is, for example, asuture placed at the distal end of the lead 241.

[0073] According to other fixation arrangements similar to thosedescribed above, and with reference to FIG. 7, the lead body 240 and/orthe electrode 230 may be configured to incorporate tissue adhesion sitesthat facilitate chronic fixation of the lead body 240 and/or electrode230 in subcutaneous tissue. For example, the adhesion sites may includevoids in the sleeve of the lead body 240 at one or more locations of thesleeve. The adhesion sites may include exposed portions of one or moreelectrodes 230 or other exposed portions of the lead 241 insulation orcovering.

[0074] According to another configuration, the adhesion sites mayinclude a structure having a porous surface that promotes subcutaneoustissue in-growth or attachment at the adhesion sites. For example, ametallic annular structure may be disposed at the adhesion site. Ametallic ring, for example, having porous surface characteristics may beemployed to promote cellular adhesion at the adhesion site. The annularstructure may incorporate the electrode 230 or be separate from theelectrode 230.

[0075] In accordance with a further configuration, the adhesion sitesmay include a material that promotes subcutaneous tissue in-growth orattachment at the adhesion sites. For example, the bulk outer sleeve ofthe lead body 240 may be constructed that includes a first polymermaterial that substantially prevents tissue in-growth. Selectiveportions of the lead body 240 may include adhesion sites formed using asecond polymer material that promotes tissue in-growth or attachmentbetween the adhesion sites and subcutaneous tissue contacting theadhesion sites. The second polymer material may, for example, have aporosity, pore sizes or distribution of pore sizes that differ from thatof the first polymer material. By way of further example, the secondpolymer material may differ in terms of hydrophobicity relative to thefirst polymer material.

[0076] In one particular configuration, the first polymer material mayinclude a first type of PTFE (polytetrafluoroethylene), and the secondpolymer material of the adhesion sites may include a second type ofPTFE. In one particular arrangement, the first type of PTFE includes afirst type of ePTFE (expanded polytetrafluoroethylene), and the secondtype of PTFE includes a second type of ePTFE. The second type of ePTFEpreferably differs from the first type of ePTFE in terms of one or moreof porosity, pore sizes or distribution of pore sizes. Additionaldetails of fixation approaches involving surface texturing, selectivematerial use, and other arrangements that facilitate lead/electrodefixation via tissue ingrowth are disclosed in commonly owned U.S. patentapplication Ser. No.10/004,708 (GUID.031 US01) filed Dec. 4, 2001 andentitled “Apparatus and Method for Stabilizing an Implantable Lead,”which is hereby incorporated herein by reference.

[0077] Now referring to FIGS. 8A and 8B, details of acute fixationelements according to another embodiment of the present invention areshown. A lead 800 is illustrated that includes a plurality of tines 810,820, 830, 840, 845 (FIG. 8B), 850, 860, 870, 880, and 890 (FIG. 8A). Thetines 810-890 are shown disposed regularly with 90 degreecircumferential placement, and regularly spaced along the length of thelead 800. However, other angles, regularity or irregularity, or numberof tines may be employed in accordance with this embodiment. The tines810-890 are shown, in this illustrative example, to be curved as theyextend from the body of the lead 800. Curvature may assist infacilitating acute fixation by providing ease of movement of the lead800 in a first direction (e.g., axial displacement in a distaldirection), while helping to set the tines into tissue in response tomovement in a second direction (e.g., axial displacement in a proximaldirection). It is contemplated that the tines may be straight, or have acurvature tending away from or toward the body of the lead 800.

[0078] Tines configured in accordance with the present invention mayalso be curved in more than one plane, as is illustrated in FIGS. 9A and9B. A lead 900 (lead and/or electrode) is shown that includes tines 910,920, 930, 935 (FIG. 9B), 940, 950, and 960 (FIG. 9A). As shown, thetines 910-960 are curved upward and away from the lead 900 relative to alongitudinal axis of the lead 900. The tines 910-960 are also curvedaround the circumference of the body of the lead 900 with respect to asecond plane of reference.

[0079] The complex curvature illustrated in FIGS. 9A and 9B may beadvantageous for optimally placing and fixing the lead 900 withinsubcutaneous tissue. This complex curvature provides for ease ofinserting and withdrawing of the lead 900 when the lead 900 is rotatedin a first direction. If the lead 900 is not rotated, the tines 910-960set into the tissue. Further, if the lead 900 is rotated in the counterdirection, the tines 910-960 may be forced into subcutaneous tissue.

[0080] Another tine configuration that employs complex curvature isillustrated in FIGS. 9C and 9D for optimally placing and fixing the lead900 within subcutaneous tissue. This complex curvature provides forfixation from proximal displacement, and from rotation of the lead 900.Tines 921, 923, 931, 933, 951, and 953 set into the tissue due to theirspring bias outwardly and upwardly from the lead 900. Placement of thistype of lead fixation may be accomplished by direct distal insertion, tocompress the tines 921, 923, 931, 933, 951, and 953 during placement andupon release of distal motion, the tines 921, 923, 931, 933, 951, and953 spring outwardly from the lead 900 for fixation.

[0081] A further tine configuration that employs complex curvature isillustrated in FIGS. 9E and 9F for optimally placing and fixing the lead900 within subcutaneous tissue. This complex curvature provides forfixation from both proximal and distal displacement, and from rotationof the lead 900. Tines 922, 932, 942, 952, 962, and 972 set into thetissue due to their spring bias outwardly and upwardly from the lead900. Placement of this type of lead fixation may be accomplished byutilization of a sheath, as described earlier, to compress the tines922, 932, 942, 952, 962, and 972 during placement, and upon removal ofthe sheath, the tines 922, 932, 942, 952, 962, and 972 spring outwardlyfrom the lead 900 for fixation.

[0082]FIG. 9G is a magnified sectional view of another embodiment of alead implemented to include a fixation arrangement in accordance withthe present invention. Tines 973 and 974 set into the tissue due totheir spring bias outwardly and upwardly from the lead 900. Placement ofthis type of lead fixation may be accomplished by utilization of asheath, as described earlier, to compress the tines 973 and 974 duringplacement, and upon removal of the sheath, the tines 973 and 974 springoutwardly from the lead 900 for fixation.

[0083]FIGS. 10A,10B, 10C and 10D illustrate various shapes for tines inaccordance with the present invention. In FIG. 10A, a tine 1010 is shownprojecting from the lead 900. The tine 1010 has a single tip 1080. Thetine 1010 is shaped to spring away from the lead 900 body.

[0084] For descriptive ease, consider a lead in the plane of FIGS. 10A,10B, 10C and 10D, with the lead 900 moving from left to right in theplane of the figures. If the lead 900 were inserted, in this drawingfrom the left to the right, the tine 1010 would tend to collapse intothe lead 900 and allow forward progress of the lead 900. If the lead 900were to be pulled from right to left in FIG. 10A, the tine 1010 wouldtend to set into tissue by the single tip 1080.

[0085] Similarly to the tine of FIG. 10A, a tine 1020 of FIG. 10B wouldalso flex and set under the same movement. However, the tine 1020, notas substantial as the tine 1010 of FIG. 10A, would more easily collapseand compress under left to right motion, and may provide less resistanceto right to left motion.

[0086] Referring now to FIG. 10C, a tine 1030 is illustrated with afirst point 1050 and a second point 1040. The shape of the tine 1030,along with the second point 1040, creates a barb 1060. The barb 1060,similar to a fishhook barb, provides for not only resistance to right toleft motion, but also for resistance to further left to right motionafter being set. This arrangement provides for ease of insertion in aleft to right direction, a resistance to right to left movement, andsubsequently also provides resistance to further left to right movementafter being set.

[0087] Referring to FIG. 10D, a straight tine 1012 is illustratedperpendicularly projecting from the lead 900 body. The straight tine1012 may be compressed and/or spring biased in the lumen of a sheath(such as, for example, the sheath 320 in FIG. 3A) during delivery of thelead 900, such that the straight tine 1012 sets into tissue when thesheath is removed. In another embodiment, the rigidity of the straighttine 1012 may be designed such that a set level of resistance isprovided by the straight tine 1012 when it is moved within tissue. Byadjusting the rigidity, the level of fixation of the lead 900, and theassociated ease of insertion/relocation, may be predetermined by design.Rigidity may be altered by material selection, geometry, of other meansknown in the art.

[0088] Referring now to FIG. 11, an ITCS system 200 is illustrated whichincludes a can 250 with a lead 241 inserted into a dissection path 220.The lead 241 includes an electrode 230, here illustrated at the distalend of the lead body 240. The subcutaneous dissection path 220 lieswithin subcutaneous tissue of a patient as illustrated in FIGS. 1A and1B. An offset helix 260 is employed as a fixation element useable to fixthe lead 241 into tissue in accordance with the present invention.Typically, the helix 260 is configured to define all or at least part ofthe electrode 230.

[0089]FIG. 12 illustrates the lead 241 inserted into the tear-awaysheath 320 as described with an earlier embodiment. After placing thelead 241 in subcutaneous tissue, the sheath 320 is retracted from thesubcutaneous tunnel, typically in a peel-away fashion. The lead 241 maybe fixed into the tissue by rotating the lead 241 as will be describedin further detail below.

[0090]FIGS. 13 and 14 show a plan view and end view respectively of anembodiment of the present invention. In FIG. 13, a helical coil 260 maybe used as a fixation element to fix the lead body 240 into tissue whenthe electrode 230 is positioned in a desired location. The helical coil260 is attached to the distal end of the lead body 240 at attachmentpoint 262. Rotation of the lead body 240 causes rotation of the helicalcoil 260, thereby rotating sharp end 400.

[0091] Although helical coil 260 is illustrated having uniform pitch,cylindrical cross-section, constant thickness of coil, it iscontemplated that any helical or screw-like structure may be used inaccordance with the present invention. The helix may be of non-uniformand/or tapering cross-section; the pitch may be non-uniform; and theshape and thickness of the coil may be varied without departing from thescope of the present invention.

[0092] As the lead 241 is rotated, the sharp end 400 contacts the wallof the dissected tissue path and penetrates into subcutaneous tissue. Asthe lead 241 is further rotated, the sharp end 400 burrows through thetissue, repeatedly penetrating the wall and progressing forward as thewinding of the helical coil 260 dictates. This effectively screws thehelical coil 260 into the wall of the tissue, thus fixing the lead 241.

[0093] In another embodiment, the helical coil 260 may be rotatableindependently of the lead 241. As the helical coil 260 is rotated orformed via extension, the sharp end 400 contacts the wall of thedissected tissue path and penetrates into subcutaneous tissue. As thehelical coil is further rotated or further extended, the sharp end 400burrows through the tissue, repeatedly penetrating the wall andprogressing forward as the winding of the helical coil 260 dictates.This effectively screws the helical coil 260 into the wall of thetissue, thus fixing the lead 241.

[0094] In the embodiment illustrated in FIGS. 13 and 14, the helicalcoil 260 is seen to be larger in diameter than the lead body 240. Anadvantage of employing the helical coil 260 that is larger than the leadbody 240 is the assurance that as the lead lies within the dissectedtissue tunnel, the sharp end 400 penetrates the tunnel wall and providefixation when rotated. If the helical coil 260 were the same size orsmaller than the lead body 240 diameter, the lead body may prevent thesharp end 400 from initiating penetration unless the lead body 240 ispushed distally along the dissection tunnel until penetration occurs.This pushing of the lead may cause the electrode 230 to be moveddistally from an optimum fixation location.

[0095] Referring now to FIGS. 15 and 16, a plan view and end viewrespectively of another embodiment of the present invention isillustrated. In FIG. 15, an offset helical coil 661 may be used as afixation element to fix the lead body 240 into tissue when the electrode230 is positioned in a desired location. The offset helical coil 661 isattached to the distal end of the lead body 240 at attachment point 662.Rotation of the lead body 240 causes rotation of the offset helical coil661, rotating sharp end 600.

[0096] As the lead body 240 is rotated, the sharp end 600 contacts thewall of the dissected tissue path and penetrates into subcutaneoustissue. As the lead body 240 is further rotated, the sharp end 600burrows through the tissue, repeatedly penetrating the wall andprogressing forward as the winding of the offset helical coil 661dictates. This effectively screws the offset helical coil 661 into thewall of the tissue, thus fixing the lead 241.

[0097] In the embodiment illustrated in FIGS. 15 and 16, as best seen inFIG. 16, the offset helical coil 661 is seen to have an offset centralaxis relative to the longitudinal axis of the lead body 240. Anadvantage of employing the offset helical coil 661 offset from the leadbody 240 is the assurance that as the lead lies within the dissectedtissue tunnel, the sharp end 600 penetrates the tunnel wall and providesfixation when rotated.

[0098] Coils 260 and 661 may be manufactured using a spring materialsuch as, for example, metal, such that coils 260 and 661 deform withinthe sheath 320 when being advanced to their fixation locations. Uponremoval of the sheath 320, coils 260 and 661 spring into their larger oroffset configurations to affect fixation into tissue. Coils 260 and 661may also be manufactured using a shape memory alloy such as, forexample, Nitinol, such that coils 260 and 661 have a first,non-penetrating shape, when being advanced through the dissection path.Upon being subjected to body temperature or artificially heated, coils260 and 661 return to a shape such as described above to affectfixation.

[0099] It should be understood that any number, type, or combination offixation elements have been contemplated, and that the number, types,and combinations presented above are by way of example only. Variousmodifications and additions can be made to the preferred embodimentsdiscussed hereinabove without departing from the scope of the presentinvention. Accordingly, the scope of the present invention should not belimited by the particular embodiments described above, but should bedefined only by the claims set forth below and equivalents thereof.

What is claimed is:
 1. An implantable lead, comprising: a lead body; acardiac electrode supported by the lead body, the cardiac electrodeconfigured for subcutaneous non-intrathoracic placement within apatient; and an expandable fixation element provided on the implantablelead, the expandable fixation element configured to expandably secureone or both of the cardiac electrode and the lead body in subcutaneousnon-intrathoracic tissue.
 2. The lead according to claim 1, wherein theexpandable fixation element is provided on the cardiac electrode.
 3. Thelead according to claim 1, wherein the expandable fixation elementcomprises a sponge.
 4. The lead according to claim 1, wherein theexpandable fixation element comprises a scleral sponge.
 5. The leadaccording to claim 1, wherein the expandable fixation element comprisesa plurality of sponges arranged in a spaced relationship.
 6. The leadaccording to claim 1, wherein the expandable fixation element comprisesan expandable portion of the lead body.
 7. The lead according to claim6, wherein the expandable portion of the lead body comprises an additivein a polymer.
 8. The lead according to claim 7, wherein the additivecomprises glycerol.
 9. The lead according to claim 6, wherein theexpandable portion of the lead body comprises an expandable polymer. 10.The lead according to claim 9, wherein the expandable polymer compriseshydrogel.
 11. The lead according to claim 1, wherein the expandablefixation element comprises an expandable collar coupled to the leadbody.
 12. The lead according to claim 11, wherein the expandable collarcomprises an additive in a polymer.
 13. The lead according to claim 12,wherein the additive comprises glycerol.
 14. An implantable lead system,comprising: a lead comprising a lead body and a cardiac electrode, thelead configured for subcutaneous non-intrathoracic placement within apatient; an expandable fixation element provided on the lead, theexpandable fixation element configured to expandably secure one or bothof the cardiac electrode and the lead body in subcutaneousnon-intrathoracic tissue; and a delivery apparatus configured tointroduce the lead to a desired subcutaneous non-intrathoracic locationwithin the patient.
 15. The lead system according to claim 14, whereinthe expandable fixation element comprises one or more sponges.
 16. Thelead system according to claim 14, wherein the expandable fixationelement comprises one or more scleral sponges.
 17. The lead systemaccording to claim 14, wherein a lumen of the delivery apparatus isdimensioned to compress the expandable fixation element while permittingaxial displacement of the lead within the lumen.
 18. The lead systemaccording to claim 14, wherein the delivery apparatus comprises a sheathhaving a longitudinal pre-stress line arrangement to facilitate sheathseparation during retraction of the sheath from the patient.
 19. Thelead system according to claim 14, wherein the expandable fixationelement is provided on the cardiac electrode.
 20. The lead systemaccording to claim 14, wherein the expandable fixation element comprisesa plurality of sponges arranged in a spaced relationship.
 21. The leadsystem according to claim 14, wherein the expandable fixation elementcomprises an expandable portion of the lead body.
 22. The lead systemaccording to claim 21, wherein the expandable portion of the lead bodycomprises an additive in a polymer.
 23. The lead system according toclaim 22, wherein the additive comprises glycerol.
 24. The leadaccording to claim 21, wherein the expandable portion of the lead bodycomprises an expandable polymer.
 25. The lead system according to claim24, wherein the expandable polymer comprises a hydrogel.
 26. The leadsystem according to claim 14, wherein the expandable fixation elementcomprises an expandable collar coupled to the lead body.
 27. The leadsystem according to claim 26, wherein the expandable collar comprises anadditive in a polymer.
 28. The lead system according to claim 27,wherein the additive comprises glycerol.
 29. The lead according to claim26, wherein the expandable collar comprises an expandable polymer. 30.The lead system according to claim 29, wherein the expandable polymercomprises a hydrogel.
 31. A method of lead stabilization, comprising:providing a lead comprising a lead body, a cardiac electrode, and anexpandable fixation element; and expandably securing one or both of thelead body and the cardiac electrode to subcutaneous non-intrathoracictissue at a fixation site using the expandable fixation element.
 32. Themethod according to claim 31, wherein the expandable fixation elementexpands to an effective diameter larger than the diameter of the leadbody to engage the subcutaneous non-intrathoracic tissue at the fixationsite.
 33. The method according to claim 31, wherein the expandablefixation element comprises one or more expandable fixation elements thatexpand to fixedly engage the subcutaneous non-intrathoracic tissue atone or more fixation sites.
 34. The method according to claim 31,further comprising modifying the position or orientation of theexpandable fixation element when the lead is advanced within the lumen.35. The method according to claim 34, wherein modifying the position ororientation comprises resiliently displacing the expandable fixationelement when the lead is advanced within the lumen.
 36. An implantablelead, comprising: a lead body; a cardiac electrode supported by the leadbody, the cardiac electrode configured for subcutaneousnon-intrathoracic placement in a patient; and means for expandablyfixing one or both of the lead body and cardiac electrode withinsubcutaneous non-intrathoracic tissue.
 37. The lead according to claim36, wherein the fixing means comprises means for acutely fixing the oneor both of the lead body and cardiac electrode within subcutaneousnon-intrathoracic tissue.
 38. The lead according to claim 36, furthercomprising a delivery apparatus comprising a sheath configured tointroduce the lead to a desired subcutaneous non-intrathoracic locationwithin the patient.
 39. The lead according to claim 38, wherein a lumenof the sheath is dimensioned to compress the fixing means whilepermitting axial displacement of the lead within the lumen.
 40. The leadaccording to claim 38, wherein the sheath comprises a longitudinalpre-stress line arrangement to facilitate sheath separation duringretraction of the sheath from the patient.
 41. A method of leaddelivery, comprising: introducing a sheath into a subcutaneousnon-intrathoracic body location of a patient; providing a leadcomprising a lead body and a cardiac electrode; advancing the leadthrough the sheath and to the subcutaneous non-intrathoracic bodylocation; expandably fixing the lead within subcutaneousnon-intrathoracic tissue; and removing the sheath from the patient. 42.The method according to claim 41, wherein removing the sheath compriseslongitudinally splitting the sheath when removing the sheath from thepatient.
 43. The method according to claim 41, wherein removing thesheath comprises enabling a fixation element for expandably fixing thelead within the subcutaneous non-intrathoracic tissue.
 44. The methodaccording to claim 41, wherein advancing the lead through the sheathcomprises modifying a position or an orientation of an expandablefixation element provided on one or both of the lead body and cardiacelectrode.
 45. The method according to claim 41, wherein advancing thelead through the sheath comprises compressing an expandable fixationelement provided on one or both of the lead body and cardiac electrode.46. The method according to claim 41, wherein fixing the lead comprisesexpanding a portion of the lead to fix one or both of the lead body andthe electrode within the subcutaneous non-intrathoracic tissue.
 47. Animplantable lead, comprising: a lead body; a cardiac electrode supportedby the lead body, the cardiac electrode configured for subcutaneousnon-intrathoracic placement within a patient; and an expandable portionprovided on the implantable lead, the expandable portion configured toprovide pores that promote tissue ingrowth for chronic fixation.
 48. Thelead according to claim 47, wherein the expandable portion comprises anadditive in a polymer.
 49. The lead system according to claim 48,wherein the additive comprises glycerol.
 50. The lead according to claim47, wherein the expandable portion comprises an expandable polymer. 51.The lead system according to claim 50, wherein the expandable polymercomprises a hydrogel.
 52. The lead system according to claim 47, whereinthe expandable portion comprises one or more sponges.
 53. The leadsystem according to claim 47, wherein the expandable portion comprisesone or more scleral sponges.
 54. The lead system according to claim 47,wherein the expandable portion comprises an expandable collar coupled tothe implantable lead.
 55. The lead according to claim 47, wherein theexpandable portion comprises first and second additives, the firstadditive configured to provide expansion and the second additiveconfigured to provide the pores.
 56. The lead according to claim 47,wherein the expandable portion comprises a polymer having first andsecond additive concentrations, the first additive concentrationconfigured to provide expansion and the second additive concentrationconfigured to provide the pores.